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IDAK — Medical Device Distribution Licence

What Is the IDAK?​

The IDAK (Izin Distribusi Alat Kesehatan — Medical Device Distribution Licence) is the mandatory licence that an Indonesian company must hold in order to import, store, and distribute medical devices — and to register devices with Kemenkes (hold the NIE).

The IDAK was previously known as the IPAK (Izin Penyalur Alat Kesehatan). All existing IPAK holders transitioning to the new system receive an IDAK on modification. A related instrument, the SDAK (Sertifikat Distribusi Alat Kesehatan), also exists but has unlimited validity — whereas the IDAK is valid for 5 years.

Only Indonesian legal entities can hold an IDAK. Foreign manufacturers must work through a local entity.

Who Needs an IDAK?​

Any Indonesian company that wishes to:

  • Import medical devices into Indonesia
  • Distribute or sell medical devices
  • Register a device with Kemenkes (hold the NIE)

How to Obtain an IDAK​

The IDAK application is submitted through the Online Single Submission (OSS) system at oss.go.id. The applicant company must already have:

  • A valid NIB (Nomor Induk Berusaha — Business Identification Number) from OSS
  • Appropriate business classification code — KBLI 46691 (Wholesale Trade of Laboratory Equipment, Pharmaceutical Devices, and Medical Devices for Humans) for wholesale distributors

Steps:

  1. Register the company on OSS and obtain NIB
  2. Submit IDAK application through OSS
  3. Provide required documentation (facility details, warehouse specifications, responsible person details, quality system information)
  4. Kemenkes reviews and issues IDAK

IDAK validity: 5 years — must be renewed before expiry.

IDAK and CDAKB: Both Required​

As of July 2024, holding an IDAK alone is no longer sufficient to submit a new NIE application. The IDAK holder must also hold a valid CDAKB (Cara Distribusi Alat Kesehatan yang Baik) — Good Distribution Practice certificate.

warning

Before selecting your Indonesian LAR or distributor, confirm they hold both a current IDAK and a current CDAKB certificate. A distributor with an IDAK but without CDAKB cannot register new devices for you.

IDAK Suspension and Your NIE​

The IDAK is directly linked to the NIE status of all devices registered under that holder. If the IDAK holder's IDAK is suspended or revoked:

  • All NIEs held by that entity are automatically frozen
  • No new imports against those NIEs can proceed
  • Distribution of existing stock may also be restricted

This risk is one of the primary reasons many foreign manufacturers prefer working with a neutral licence holder rather than their commercial distributor for NIE purposes.